Etruzil 2.5mg 30 tablets — Made in Hungary — Free Delivery

Product description

Etruzil tablets are used for the following indications:

• adjuvant therapy of hormone-positive invasive breast cancer in the early stages in postmenopausal women;
• extended adjuvant therapy for early invasive breast cancer in postmenopausal women who have received standard adjuvant tamoxifen therapy for 5 years;
• first-line therapy for hormone-dependent advanced breast cancer in postmenopausal women;
• treatment of common forms of breast cancer in postmenopausal women (natural or induced) after relapse or progression of the disease, who received prior antiestrogen therapy;
• neoadjuvant therapy in postmenopausal women with hormone-positive, HER-2-negative breast cancer who are not suitable for chemotherapy and are not indicated for urgent surgery.

The effectiveness of the preparation for patients with hormone-negative breast cancer has not been proven.

Compound

The active ingredient is letrozole (one coated tablet contains 2.5 mg letrozole).

Excipients: lactose, monohydrate; microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate (type A), magnesium stearate, anhydrous colloidal silicon dioxide, hypromellose, talc, macrogol 8000, titanium dioxide (E171), iron oxide yellow (172).

Contraindications

• hypersensitivity to letrozole or to any excipients of the preparation;
• endocrine premenopausal status, pregnancy, lactation period;
• severe liver failure;
• preoperative use of the preparation if the status of the receptors is negative or unknown;
• women of reproductive age.

Mode of application

Adults, including elderly patients

The recommended dose of Etruzil is 2.5 mg once a day. In adjuvant and extended adjuvant therapy, treatment with Etrusil should be continued for 5 years or until a relapse occurs. Patients with metastases should be treated with Etruzil until signs of disease progression become evident. In the context of adjuvant treatment, the possibility of using a sequential therapy regimen (letrozole for 2 years, followed by a switch to tamoxifen for 3 years) should also be considered.

In neoadjuvant conditions, therapy with Etrusil should be continued for 4-8 months in order to achieve optimal tumor shrinkage. If the response to treatment is insufficient, therapy with Etruzil should be discontinued and planned surgery should be prescribed and / or further treatment options should be discussed with the patient.

For elderly patients, dose adjustment of the preparation is not required.

Method of use

The preparation "Etrusil" should be taken orally, regardless of food intake, since food does not affect the degree of absorption.

The missed dose should be taken as soon as the patient remembers it. However, if the patient remembers this shortly before taking the next dose (2-3 hours), the missed dose should be skipped and the next dose should be taken according to the schedule. You should not take a double dose, because when taking a daily dose higher than the recommended 2.5 mg, a systemic exposure higher than the proportional one was observed.

Application features

Children

The preparation should not be used in children, since the efficacy and safety of letrozole for this category of patients have not been studied in clinical trials.

Drivers

The influence of the preparation "Etruzil" on the ability to drive vehicles and work with mechanisms is insignificant. Since during the treatment with the preparation, patients experienced general weakness and dizziness, as well as in some cases - drowsiness, caution is recommended when driving or working with complex mechanisms.

Overdose

Reported isolated cases of overdose with letrozole.

The specific treatment for overdose is unknown; treatment should be symptomatic and supportive.

Side effects

In general, the adverse reactions that were observed were predominantly mild or moderate and in most cases were associated with estrogen deficiency. The most common adverse reactions reported in clinical study reports were hot flashes, hypercholesterolemia, arthralgia, nausea, increased sweating, and fatigue. Important adverse reactions that can develop during treatment with letrozole include phenomena from the musculoskeletal system, such as osteoporosis and / or bone fractures, and phenomena from the cardiovascular system (including cerebrovascular and thromboembolic events). Many side effects can be attributed to the natural pharmacological consequences of estrogen deficiency (eg hot flashes, alopecia, or vaginal bleeding). Most of the adverse reactions were observed in the first few weeks of treatment.

Storage conditions

Store at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life is 3 years.